Pilot Explorations of Neurofeedback Issues in ADHD

描述（由申请人提供）：神经反馈（EEG生物反馈）越来越多地被提倡用于治疗注意力缺陷/多动障碍（ADHD），尽管证据基础薄弱。大量的开放和部分对照研究存在严重的设计缺陷，特别是缺乏盲法和罕见的随机化。特别是，没有发表的双盲随机临床试验（RCT）。本R34试点申请的主要目的是通过解决几个可行性/效率/适口性问题来确定适当的设计，为这样的RCT做准备。这些因素包括治疗的频率和次数，以及新技术致盲的可行性。次要目的包括通过改进的盲法技术，复制先前研究中发现的效应大小（d>0.7），并探索年龄、性别和ADHD亚型的影响。36名年龄在6-12岁、严格诊断为DSM-IV ADHD、目前未服用药物的男孩和女孩将被两次随机化：首先接受主动神经反馈（n=24）和假神经反馈（n=12），同时接受每周2次和3次治疗频率（每个频率18次，12次主动和6次假），共接受40种治疗。在第24次治疗时，主要评估将包括满意度和盲化措施，并且受试者将可以选择切换到剩余16次治疗的相反治疗频率，以产生计划适口性的实际衡量标准。主要评估（基线、治疗12、治疗24、治疗40和随访）将包括症状测量、功能损害、学业表现/成就，以及注意力、警惕性和执行功能的神经心理测试。每3种治疗方式中家长会对ADHD症状进行评分每6种治疗方式中教师会对ADHD症状进行评分，以跟踪一段时间的反应曲线。基线EEG觉醒和ADHD亚型将作为可能的调节因素进行检查。通过确定治疗的最佳频率和次数，并证明双盲的可行性，该初步研究应为神经反馈的明确大型随机对照试验铺平道路。注意缺陷/多动障碍（ADHD）是最常见的儿童精神障碍，对学业、社会/婚姻、职业功能甚至安全都有重大影响。由于目前已建立的治疗方法对几乎一半的患者来说都不是最理想的，而且许多人对最有效的治疗方法（兴奋剂药物）的疗效有所下降，因此公共卫生需要更多的治疗选择，如神经反馈（脑电图生物反馈），它有令人鼓舞的初步开放和部分对照研究，但没有发表双盲研究。由于其费用和费力的强度，需要严格的测试，而本应用程序正是为了满足这一需求，提出了一项试点研究，以解决一些可行性和设计问题，为大型双盲随机试验做准备。

DESCRIPTION (provided by applicant): Neurofeedback (EEG biofeedback) is increasingly advocated for treatment of attention-deficit/hyperactivity disorder (ADHD) despite a thin evidence base. The numerous open and partially controlled studies suffer serious design flaws, especially lack of blinding and rare randomization. In particular, there is no published double-blind randomized clinical trial (RCT). The primary aim of this R34 pilot application is to prepare for such a RCT by resolving several feasibility/efficiency/palatability issues that would determine appropriate design. These include the frequency and number of treatments and feasibility of blinding with new technology. Secondary aims include to replicate, with an improved blinding technique, the effect sizes (d>0.7) found in prior studies and to explore age, sex, and ADHD subtype effects. Thirty-six boys and girls aged 6-12 with rigorously diagnosed DSM-IV ADHD not currently taking medication will be twice-randomized: first to active neurofeedback (n=24) vs. sham neurofeedback (n=12), and simultaneously to 2 vs. 3 times a week treatment frequency (18 in each frequency, 12 active and 6 sham) for 40 treatments. At treatment 24, major assessments will include measures of satisfaction and blinding, and subjects will be given the option of switching to the opposite treatment frequency for the remaining 16 treatments to generate a practical measure of schedule palatability. Major assessments (at baseline, treatment 12, treatment 24, treatment 40, and follow-up) will include measures of symptoms, functional impairment, academic performance/achievement, and neuropsychological tests of attention, vigilance, and executive functioning. Every 3 treatments parents will rate ADHD symptoms and every 6 treatments teachers will rate, to track the response curve over time. Baseline EEG arousal and ADHD subtype will be examined as possible moderators. By determining the optimal frequency and number of treatments and demonstrating feasibility of double blinding, this pilot study should pave the way for a definitive large RCT of neurofeedback. Attention-deficit/hyperactivity disorder (ADHD) is the most common child mental disorder, with significant impact on academic, social/marital, and occupational function, and even on safety. Because current established treatments are less than optimal for almost half of patients and many decline the most effective ones (stimulant medication), there is a large public health need for additional treatment options such as neurofeedback (EEG biofeedback), which has encouraging preliminary open and partially controlled studies but no published double-blind studies. Because of its expense and laborious intensity, rigorous testing is needed, and this application is in response to that need, proposing a pilot study to resolve some feasibility and design issues preparatory to a large double-blind randomized trial.